- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987568
Characterize Tumor Hypoxia by Magnetic Resonance Imaging
December 19, 2022 updated by: Wake Forest University Health Sciences
To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients
The purpose of this research study is to measure the hypoxia (low oxygen condition) in prostate cancers and its effect in survival.
In this study, investigators will assess hypoxia by magnetic resonance imaging (MRI) and create a hypoxia score.
Investigators will study the hypoxia score and how it correlates (if any) to the disease aggressiveness as well as its effect on the treatment outcomes.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Primary Objective(s):
- To assess hypoxia in primary prostate tumors by magnetic resonance imaging.
- To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression).
Secondary Objective(s):
- To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient.
- To correlate hypoxic score with fatty acid synthase (FASN) expression.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- The minimum age for this study is men 40 years and older. Prostate cancer mainly affects men over the age of 40.
- Patients with Caucasian and African American race
- Patients with pathology-proven prostate cancer (Gleason 6 or higher)
- Patients who have not yet undergone therapy (systemic drugs, radiation, or prostatectomy)
- Patients who will have a radical prostatectomy as standard of care.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion Criteria:
- Patients who have already received some form of treatment or are not planning to undergo radical prostatectomy for treatment.
- Patients with any other cancer along with prostate cancer.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (MRI biospecimen collection)
Patients undergo MRI over 15 minutes before standard of care surgery.
Patients also undergo collection of blood samples during MRI and at the time of surgery.
|
Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.
At the beginning of study magnetic resonance imaging MRI will be completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Tumor Hypoxia Scores Between Subgroups
Time Frame: 30 days
|
Using MRI parameters including apparent diffusion coefficient and fractional blood value four race/score combination groups (African-Americans with Gleason score 6; African-Americans with Gleason score greater than or equal to 7; Caucasians with Gleason score 6; and Caucasian with Gleason score greater than or equal to 7) to calculate the correlation coefficients estimates between hypoxic scores using Pearson correlation coefficient and Spearman's rank correlation coefficient.
|
30 days
|
Number of Biomarkers Expressed
Time Frame: 30 days
|
Expression of proliferation biomarkers (Ki-67 and PCNA) to calculate the correlation coefficients estimates between expression of proliferation biomarkers using Pearson correlation coefficient and Spearman's rank correlation coefficient.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ExoHypoxic Concentrations in Plasma
Time Frame: 30 days
|
The associations between hypoxic score and candidate biomarkers for ExoHypoxic concentration (number per milliliter plasma) will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.
|
30 days
|
Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations
Time Frame: 30 days
|
The associations between hypoxic score and fatty acid synthase expression will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gagan Deep, Ph.D, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2019
Primary Completion (Actual)
November 15, 2021
Study Completion (Actual)
November 15, 2021
Study Registration Dates
First Submitted
June 13, 2019
First Submitted That Met QC Criteria
June 13, 2019
First Posted (Actual)
June 17, 2019
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 19, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00059037
- P30CA012197 (U.S. NIH Grant/Contract)
- WFBCCC 03319 (Other Identifier: Wake Forest Baptist Comprenhensive Cancer Center)
- NCI-2019-04690 (Other Identifier: National Cancer Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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